Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

Post Streptococcal Reactive Arthritis Clinical Trial

Official title:

Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179451
• Other study ID #: MMC10040-10CTIL
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: February 19, 2013
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• PSRA patients under 18 who were diagnosed at least one year prior to the study

Exclusion Criteria:

• PSRA patients under 18 who were diagnosed less one year prior to the study

• patients who do not fulfill PSRA criteria

• patients who fulfill Jones criteria

• patients with a known heart defect

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Reactive
• Post Streptococcal Reactive Arthritis

Intervention

Device:
• echocardiogram
echocardiogram

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac valve function		at least 1 year after termination of antibiotic treatment	No